An observational study in Early-Onset Scoliosis Deformity of Spine, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 5 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by University of Michigan · Observational
The investigators are conducting research to compare serum and urine titanium levels in children with early onset scoliosis who are being treated with certain types of metal spinal rods. These rods include traditional growing rods (TGR), magnetically-controlled growing rods (MCGR), and Vertical Expandable Prosthetic Titanium Rib (VEPTR). Children with metal rods may have elevated serum and urine titanium levels. These levels may remain elevated over time. The investigators will collect serum titanium levels from children with metal rods and children without metal rods to see if there are differences in their titanium levels. The investigators will then collect a second serum titanium level from children with metal rods at least 6 months later to see if the participants titanium levels remain elevated over time. The investigators will also collect urine titanium levels from children with metal rods to see if titanium is excreted in the urine.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 38 is below the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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The study population will be patients treated by the Pediatric Orthopaedic Surgery department at Michigan Medicine.
Cases: Patients with early onset scoliosis treated with traditional growing rods (TGR), magnetically controlled growing rods (MCGR), and the Vertical Expandable Prosthetic Titanium Rib (VEPTR).
Controls: Patients with operative fractures.
Exclusion Criteria:
Cases: Patients who had a previous limited spinal fusion, conversion from one type of GSI to another, TGR with stainless steel or cobalt chromium instrumentation, and indwelling implants for 6 months or less.
Controls: Patients with indwelling implants or prior implant insertion and removal.
Patients with early onset scoliosis treated with growth-sparing instrumentation (TGR, MCGR, and, VEPTR).
Combination Product: Growth-sparing instrumentation and titanium levels
Patients with operative fractures.
Patients with growth-sparing instrumentation as treatment for early onset scoliosis, will have their titanium (serum and urine) levels tested, to evaluated if they have elevated titanium levels compared to a control group.
Serum titanium levels between groups
Compare serum titanium levels in patients with EOS treated with titanium alloy TGR, MCGR, and VEPTR to age-matched controls.
Time frame: At enrollment
Serial serum titanium levels in scoliosis patients
Collect serial serum titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.
Time frame: Roughly 6 months apart
Urine titanium levels in scoliosis patients
Collect urine titanium levels in patients with EOS treated with TGR, MCGR, and VEPTR.
Time frame: At enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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